Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
NCT ID: NCT06822790
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
869 participants
INTERVENTIONAL
2025-04-09
2028-07-31
Brief Summary
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Subjects who previously met all eligibility requirements for AROAPOC3-3003 or AROAPOC3-3004 and were not permitted to proceed to randomization per the Sponsor's direction in order to prevent excessive over-enrollment may also be enrolled in this trial. The subjects must meet all other applicable eligibility criteria prior to enrollment and have an HbA1c results of \<=10% within 30 days prior to Day 1.
Subjects entering this OLE from AROAPOC3-2003 must meet the following additional criteria to be considered for enrollment in addition to applicable eligibility criteria:
1. HbA1c ≤10% within 30 days prior to Day 1
2. Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND fulfill either (c) or (d)
3. Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001
4. Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
All eligible participants will receive plozasiran administered subcutaneously (SC) approximately every 3 months for 24 months. Participants will be counseled to remain on the specified low-fat diet throughout the study in accordance with local standard of care.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Plozasiran Injection
8 doses of plozasiran (ARO-APOC3) administered by subcutaneous (SC) injection
Plozasiran Injection
ARO-APOC3 injection
Interventions
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Plozasiran Injection
ARO-APOC3 injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed all required study visits per protocol in the parent study
* Female subjects of childbearing potential must agree to use a highly effective method of contraception during the study and for at least 90 days after the End of Study (EOS) or the last dose of plozasiran, whichever is later. Male subjects must agree to use a condom during the study and for at least 90 days after the EOS or last dose of plozasiran whichever is later. Subjects must not donate sperm or eggs during the study and for at least 90 days after the EOS or last dose of plozasiran, whichever is later. Female subjects of childbearing potential on hormonal contraceptives must be stable on medication for \>1 menstrual cycle prior to Day 1.
* Subjects must be on standard of care lipid and TG-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator, including an inability to safely administer or re-administer a specific drug because of fear, preference, genetic, clinical, or metabolic considerations, or due to a previous adverse reaction associated with, attributed to, or caused by specific drug)
* If the subject has a medical history of clinical atherosclerotic cardiovascular disease (ASCVD) or elevated 10-year ASCVD risk (eg, ≥7.5% per American Heart Association/American College of Cardiology \[AHA/ACC\] risk calculator for subjects ≥40 years of age or Framingham risk score calculator for subjects under the age of 40), the subject must be on appropriate lipid-lowering therapy as per local standard of care (ie, including moderate-to-high intensity statin, as indicated).
If the subject has diabetes:
1. Subject must be on optimized antidiabetic regimen as defined by the local standards, Investigator, and institutional practices
2. Subject must have no events of diabetic ketoacidosis, diabetic decompensation/ hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks of the Day 1 visit - Willing to follow diet counseling and maintain a stable low-fat diet
* HbA1c ≤10% within 30 days prior to Day 1
* Completed AROAPOC3-2001 prior to entry into AROAPOC3-2003 AND either (c) or (d) below:
* Baseline fasting TG level of ≥500 mg/dL and prior history of acute pancreatitis at the time of enrollment into AROAPOC3-2001
* Baseline fasting TG level of ≥1000 mg/dL at the time of enrollment into AROAPOC3-2001
Exclusion Criteria
* Subject withdrew consent for continued study treatment in the parent study
* Known hypersensitivity to the active substance or to any of the excipients of plozasiran
* Known hypersensitivity to the active substance or to any of the excipients of plozasiran
* Any new condition or worsening of existing condition or any other situation that in the Investigator's judgment, would make the subject unsuitable for enrollment, could interfere with the subject participating in or completing the study, would make it difficult to comply with protocol requirements, or put the subject at an additional safety risk
* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study.
* Poorly controlled glycemia (ie, HbA1c \>10%) based upon the most recent HbA1c level reported in the parent trial prior to Day 1
* Acute pancreatitis within 4 weeks prior to Day 1
* Use of any hepatocyte-targeted siRNA that targets lipids and/or triglycerides within 365 days before Day 1 (except plozasiran or inclisiran, which are permitted). Administration of inclisiran must be separated from administration of plozasiran by at least 4 weeks throughout the treatment period
* Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives before Day 1 based on plasma PK, whichever is longer.
* Use of an investigational agent (other than plozasiran) or device within 30 days or within 5 half-lives, based on plasma PK, whichever is longer, prior to Day 1 (V1) or current participation in an interventional investigational study.
* Recent unstable or symptomatic cardiac arrhythmia (including any associated medication changes) within 90 days prior to Day 1. Individuals with stable well-controlled atrial arrhythmias will be allowed to participate in the study.
* Uncontrolled hypertension (ie, seated systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg) at Day 1; subject may be re-evaluated when hypertension is controlled.
18 Years
ALL
No
Sponsors
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Arrowhead Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Research Site 21
Bakersfield, California, United States
Research Site 9
Beverly Hills, California, United States
Research Site 11
Canoga Park, California, United States
Research Site 39
Lincoln, California, United States
Research Site 34
Oxnard, California, United States
Research Site 14
Hialeah, Florida, United States
Research Site 1
Miami Lakes, Florida, United States
Research Site 38
North Miami, Florida, United States
Research Site 16
Tamarac, Florida, United States
Research Site 18
Tampa, Florida, United States
Research Site 17
Park Ridge, Illinois, United States
Research Site 28
Overland Park, Kansas, United States
Research Site 23
Topeka, Kansas, United States
Research Site 12
Annapolis, Maryland, United States
Research Site 30
Flint, Michigan, United States
Research Site 33
Jackson, Mississippi, United States
Research Site 32
Olive Branch, Mississippi, United States
Research Site 2
Jefferson City, Missouri, United States
Research Site 29
Fremont, Nebraska, United States
Research Site 3
Omaha, Nebraska, United States
Research Site 37
Asheboro, North Carolina, United States
Research Site 36
Morehead City, North Carolina, United States
Research Site 22
Beavercreek, Ohio, United States
Research Site 31
Oklahoma City, Oklahoma, United States
Research Site 26
Horsham, Pennsylvania, United States
Research Site 8
Newport, Pennsylvania, United States
Research Site 27
El Paso, Texas, United States
Research Site 24
Houston, Texas, United States
Research Site 13
Sugar Land, Texas, United States
Research Site 25
Victoria, Texas, United States
Research Site 15
Bountiful, Utah, United States
Research Site 35
St. George, Utah, United States
Research Site 10
Manassas, Virginia, United States
Research Site 20
Victoria, British Columbia, Canada
Research Site 7
London, Ontario, Canada
Research Site 6
Chicoutimi, Quebec, Canada
Research Site 5
Montreal, Quebec, Canada
Research Site 19
Québec, Quebec, Canada
Research Site 4
Québec, Quebec, Canada
Countries
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Central Contacts
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Other Identifiers
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AROAPOC3-3006
Identifier Type: -
Identifier Source: org_study_id
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